EMBOZENE MICROSPHERES

Device, Vascular, For Promoting Embolization

CELONOVA BIOSCIENCES, INC.

The following data is part of a premarket notification filed by Celonova Biosciences, Inc. with the FDA for Embozene Microspheres.

Pre-market Notification Details

Device IDK132675
510k NumberK132675
Device Name:EMBOZENE MICROSPHERES
ClassificationDevice, Vascular, For Promoting Embolization
Applicant CELONOVA BIOSCIENCES, INC. 18615 Tuscany Stone Ste 100 San Antonio,  TX  78258
ContactNicole Barber
CorrespondentNicole Barber
CELONOVA BIOSCIENCES, INC. 18615 Tuscany Stone Ste 100 San Antonio,  TX  78258
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-28
Decision Date2013-10-03
Summary:summary

Trademark Results [EMBOZENE MICROSPHERES]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EMBOZENE MICROSPHERES
EMBOZENE MICROSPHERES
86268331 4684062 Live/Registered
BOSTON SCIENTIFIC LIMITED
2014-05-01

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